MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK COMPREHENSIVE HUMERAL STEM; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Feldman jj, duquin tr, azar fm, throckmorton tw.Preliminary results of reconstruction of proximal humeral bone loss with a reverse total shoulder prosthesis using a modular endoprosthetic reconstruction system: a case series.Current orthopaedic practice.Vol.31, no.5 (2020).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.

Event Description

It was reported per a journal article from current orthopaedic practice (2020) that reported a study from the united states that looked at the use of a modular endoprosthetic reconstruction system with a reverse total shoulder arthroplasty for massive proximal humeral bone loss.The purpose of the study was to evaluate the preliminary outcomes of reconstruction with this device in patients with massive proximal humeral bone loss.The study reviewed twelve (12) patients with massive (>4cm) proximal humeral bone loss who had reconstruction with a reverse total shoulder arthroplasty using a single modular endoprosthetic system (comprehensive segment revision system, zimmer biomet).A standard deltopectoral approach was utilized, and all but one of the prostheses were press-fit; the other was cemented because of poor bone quality.The indication for revision was proximal humeral fracture (2), tumor (3), infection (3), gorham disease (1), and failed arthroplasty (3).The study population had a mean age of 62.8 years at time of surgery (range 22-79 years).Average follow-up was 2.1 years (range 1-3.1 years).The study reported one patient was revised to a long cemented stem due to stem loosening.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product location unknown.

Event Description

No further event information available at the time of this report.

• Brand Name: UNK COMPREHENSIVE HUMERAL STEM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11229296
• MDR Text Key: 231685748
• Report Number: 0001825034-2021-00145
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR